temozolomide in treating patients with mycosis fungoides or sezary syndrome

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. purpose: this phase ii trial is studying temozolomide to see how well it works in treating patients with mycosis fungoides or sezary syndrome that has not responded to previous treatment.

objectives: * determine the response rate to temozolomide in patients with relapsed mycosis fungoides or sezary syndrome. * determine the toxic effects of this drug in these patients. * correlate pretreatment agt activity in tumor cells with response to this drug in these patients. outline: this is a multicenter study. patients receive oral temozolomide once daily on days 1-5. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity for a maximum of 1 year. patients are followed every 3 months. projected accrual: a total of 12-37 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * histologically confirmed mycosis fungoides or sezary syndrome * stage ib-ivb disease * must have failed at least one prior systemic therapy * generalized erythroderma allowed * measurable disease and at least one indicator lesion or evaluable disease for erythrodermic patients only * prior radiotherapy to areas of measurable disease allowed if disease progression is present in the site or if measurable disease is present outside irradiation port patient characteristics: age: * 18 and over performance status: * ecog 0-2 or * who 0-2 life expectancy: * at least 3 months hematopoietic: * wbc at least 3,000/mm\^3 * absolute granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 2.2 mg/dl * sgot or sgpt no greater than 2 times upper limit of normal (uln) * alkaline phosphatase no greater than 2 times uln renal: * creatinine no greater than 2.0 mg/dl cardiovascular: * no new york heart association class iii or iv heart disease * no clinically significant peripheral venous insufficiency other: * hiv negative * no poorly controlled diabetes mellitus * no acute infection requiring iv antibiotics * no other medical condition that would prevent ingestion or absorption of oral medication * no other neoplasm within the past 5 years except curatively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * at least 4 weeks since prior biologic therapy and recovered * no concurrent growth factors or epoetin alfa chemotherapy: * at least 4 weeks since prior chemotherapy and recovered endocrine therapy: * at least 4 weeks since prior topical steroids radiotherapy: * see disease characteristics * at least 2 weeks since prior radiotherapy for local control or palliation and recovered surgery: * recovered from prior major surgery other: * no other concurrent investigational drugs

Keywords: stage i cutaneous t-cell non-hodgkin lymphoma stage ii cutaneous t-cell non-hodgkin lymphoma stage iii cutaneous t-cell non-hodgkin lymphoma stage iv cutaneous t-cell non-hodgkin lymphoma recurrent cutaneous t-cell non-hodgkin lymphoma stage i mycosis fungoides/sezary syndrome stage ii mycosis fungoides/sezary syndrome stage iii mycosis fungoides/sezary syndrome stage iv mycosis fungoides/sezary syndrome recurrent mycosis fungoides/sezary syndrome